CN101040799A - Composite end effector for an ultrasonic surgical instrument - Google Patents

Composite end effector for an ultrasonic surgical instrument Download PDF

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Publication number
CN101040799A
CN101040799A CNA2007100894201A CN200710089420A CN101040799A CN 101040799 A CN101040799 A CN 101040799A CN A2007100894201 A CNA2007100894201 A CN A2007100894201A CN 200710089420 A CN200710089420 A CN 200710089420A CN 101040799 A CN101040799 A CN 101040799A
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China
Prior art keywords
end effector
composite
ultrasonic energy
characteristic value
energy input
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CNA2007100894201A
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CN101040799B (en
Inventor
K·L·豪泽
F·B·斯图伦
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation

Abstract

A composite end effector for an ultrasonic surgical instrument is provided and includes a first portion formed from a first material that exhibits a first characteristic value when excited by an ultrasonic energy input and a second portion formed from a second material that exhibits a second characteristic value when excited by the ultrasonic energy input. The composite end effector exhibits a composite characteristic value different from the first and second characteristic values when excited by the ultrasonic energy input.

Description

The composite end effector that is used for ultrasonic surgical instrument
Technical field
The present invention relates to ultrasonic surgical instrument, more specifically, relate to ultrasonic surgical instrument with cutting and the used end effector of coagulating tissue.
Background technology
The surgeon uses ultrasonic instrument to cut in operation and coagulating tissue.Resonant frequency electricity with ultrasonic instrument excites piezoelectric element to produce vibration, and this vibration is transmitted by resonator, and this vibration is exaggerated to produce the mechanical stationary wave vibration of same frequency.The ultrasound-transmissive assembly of apparatus has elongated transmission waveguide pipe, and this waveguide is with the end effector (for example cutting blade) of this vibration transmission to the distal end that is positioned at apparatus.End effector can mainly vibrate in the vertical, with the local heat that produces in the nigh tissue, but some apparatuses distinguishingly have been designed to make end effector mainly in laterally upward vibration of (perpendicular to longitudinal axis) or torsional direction (around longitudinal axis), with treated tissue.
The distal end of end effector is corresponding to vibratory anti-nodal point.The near-end of end effector is mounted to waveguide usually and is positioned at the distally slightly of the farthest side vibration nodal point of ultrasound-transmissive assembly.This layout allows when end effector is not arranged in tissue apparatus to be adjusted to preferred resonant frequency.Therefore, by limiting, the length of end effector is slightly less than 1/4th of wave length of sound, and this sound wave is to propagate to pass the sound wave of end effector material when the ultrasonic energy input by characteristic frequency excites.
The ultrasonic surgery end effector that is formed by different materials can have visibly different acoustics and mechanical property.These characteristics can be relevant with the material behavior such as ultrasonic propagation wavelength, heat conductivity, mechanical fatigue strength and transaudient efficient.For example, the end effector that is formed by the relative higher material (for example pottery) of ratio of elastic modelling quantity and density can have longer transonic wavelength than the end effector that is formed by the material with relatively low ratio (for example metal).
The end effector of some existing ultrasonic surgical instruments is made by the Ti-6Al-4V titanium alloy.When operating with the supersonic frequency of 55.5kHz, the transonic wavelength of titanium alloy is approximately 87mm, makes that the length of end effector is about 22mm.Use for some surgeries, the surgeon can preferably slightly long than existing end effector end effector.
Wave length of sound in the material equals the frequency (cycle per second) that the velocity of sound in the material is imported divided by ultrasonic energy.Therefore, providing a kind of method of the apparatus with longer end effector is to reduce the frequency of ultrasonic energy input.For example, frequency is reduced to about 27.8kHz from about 55.5kHz and the characteristic wavelength the titanium alloy can be increased to about 174mm.But stimulating frequency has a concrete lower limit.End effector near the 22kHz vibration can produce poignant sound, clearly is undesired in the Surgical Operating Room therefore.
The another kind of method that apparatus with longer end effector is provided is the end effector material that selects a sound and can comparatively fast propagate therein.The velocity of sound in the material is the function of density of material and elastic modelling quantity.Basically, the higher material of elastic modelling quantity and the ratio of density can be than the propagate ultrasonic energy quickly of the material with low ratio.Some ceramic materials (comprise aluminium oxide (Al 2O 3)) characteristic wavelength that shows approximately is the twice of some titanium alloys.Unfortunately, ceramic material is highly brittle, and in normal gripping, assembling and operation, the end effector of pottery is easily damaged.
Except long end effector is provided, also may need to improve the transaudient efficient of end effector, also reduce the time that is used to cut and make coagulation of tissues with " self-heating " that reduces end effector.Some materials such as sapphire, titanium and aluminum can more effectively transmit ultrasonic energy than the material such as copper and steel.The transaudient efficient of surgery ultrasonic end-effector can be relevant with the sonic system number that does not have unit, and this sonic system number is known in the industry as " Q " coefficient, and for Ti-6Al-4V titanium alloy and some aluminium alloys, the sonic system number is in 10000 to 20000 scope.The Q coefficient of some steel can be low to moderate 250.For the application that the self-heating of end effector should be minimized, end effector can be formed by the higher material of Q coefficient.But, also exist some surgeries of the quick self-heating that needs end effector to use, when for example when end effector immerses in the body fluid, using.For such application, in order to produce heat fast to cut and to make coagulation of tissues in tissue, end effector can be formed by the lower material of Q coefficient.
The heat conductivity of end effector material can also influence end effector significantly and how cut and to make coagulation of tissues apace.If end effector conducts to tissue too quickly with heat, then tissue may be burnt out.But, if crossing, end effector conducts heat to tissue slowly, then device cutting and/or agglomerative speed are slow excessively.Use according to surgery, the end effector that is formed by Ti-6Al-4V alloy (heat conductivity is approximately 7W/m-K) may keep too much heat, and may walk too much heat from taeniae telarum by the end effector that aluminum (heat conductivity is approximately 200W/m-K) forms.
Therefore the mechanical fatigue strength of end effector material can influence the working life of end effector significantly, and influences end effector and can be used in number of times in the surgical procedure.Fatigue strength is known as the fatigue limit of material sometimes, and corresponding to material in fact can be by reversed of stress stress many times the time.The Ti-6Al-4V alloy has the fatigue strength of about 41kPa, and the fatigue strength of aluminum is approximately 138kPa.Aluminum is also soft than titanium alloy, is damaged by other surgical instrumenties therefore in use easilier, therefore may cause producing the crackle that the fatigue resistance that makes end effector further reduces.
Be clear that the design of surgery ultrasonic end-effector has been subjected to challenge at least in part, because use the required acoustics and the single end effector material of combination of mechanical properties for having some surgeries, available selection is very limited.For example, may need to provide a kind of and have the surgery ultrasonic end-effector of longer transonic wavelength and bigger fatigue strength than existing end effector, it can also keep the acoustic efficiency and the thermal characteristics of existing end effector.
Therefore, need a kind of surgery ultrasonic end-effector, it has the combination of some required acoustics and/or mechanical performance, this combination be traditional end effector of forming by single material can not provide.
Summary of the invention
In one embodiment, the composite end effector that is used for ultrasonic surgical instrument has first that is formed by first material and the second portion that is formed by second material, first material list reveals first eigenvalue when being excited by the ultrasonic energy input, and second material list reveals second eigenvalue when being excited by the ultrasonic energy input.When being excited by the ultrasonic energy input, composite end effector shows the composite characteristic value that is different from first and second eigenvalues.
In another embodiment, the composite end effector that is used for ultrasonic surgical instrument has a plurality of parts, wherein each part is by a kind of formation the in the multiple material, and wherein every kind of material is being shown eigenvalue by the ultrasonic energy input when exciting, and wherein composite end effector is being shown the composite characteristic value different with any one eigenvalue by the ultrasonic energy input when exciting.
In another embodiment, the composite end effector that is used for ultrasonic surgical instrument has a plurality of parts that formed and linked together by material, makes composite end effector show enhanced resistance to the crack propagation that passes end effector when being excited by the ultrasonic energy input.At least one part is the laminated portions that is connected on the adjacent part, makes the crackle that produces in laminated portions can not propagate and passes adjacent part.
The present invention is specifically related to:
(1) a kind of composite end effector that is used for ultrasonic surgical instrument comprises:
By the first that first material forms, described first material is being shown first eigenvalue by the ultrasonic energy input when exciting; And
By the second portion that second material forms, described second material is being shown second eigenvalue by described ultrasonic energy input when exciting;
Wherein, described composite end effector shows and the different composite characteristic value of described first and second eigenvalues when being excited by described ultrasonic energy input.
(2) as (1) described composite end effector, wherein, described composite characteristic value is in by the described first and second eigenvalue restricted portions.
(3) as (1) described composite end effector, wherein, described first, second and composite characteristic value comprise at least a in transonic wavelength, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and the mechanical fatigue strength.
(4) as (1) described composite end effector, wherein, described first, second and composite characteristic value are the transonic wavelength, and the length of described composite end effector approximates 1/4th of described composite characteristic value greatly.
(5), wherein, vibrate on described composite end effector at least one in vertical, horizontal and torsional direction of longitudinal axis with respect to described composite end effector as (1) described composite end effector.
(6) as (1) described composite end effector, wherein, described first end comprises the chamber that keeps described second portion.
(7) as (1) described composite end effector, wherein, described first material comprises at least a in aluminium alloy and the titanium alloy.
(8) as (7) described composite end effector, wherein, described second material comprises at least a in aluminium alloy, titanium alloy, aluminium oxide ceramics, sapphire, ruby, aluminium nitride, zirconium oxide, carborundum, silicon nitride, silver, copper, gold and the copper alloy.
(9) as (6) described composite end effector, wherein, described chamber is vertical hole, and described second portion fills up described hole basically.
(10) as (1) described composite end effector, wherein, described first is connected to described second portion by at least a in sintering process, soldering processes and the mechanical technology.
(11) a kind of transmission assembly that is used for ultrasonic surgical instrument, described ultrasonic surgical instrument comprises the end effector that is formed by two-layer at least, ground floor in the described layer is formed by first material, the second layer in the described layer coaxially is received on the described ground floor and by second material that is different from described first material and forms, wherein, when being excited by the ultrasonic energy input, described first material list reveals first eigenvalue, when being excited by described ultrasonic energy input, described second material list reveals second eigenvalue, when being excited by described ultrasonic energy input, described end effector shows composite characteristic value, and described composite characteristic value is different from described first and second eigenvalues.
(12) as (11) described transmission assembly, wherein, described composite characteristic value is the eigenvalue between described first and second eigenvalues.
(13) as (11) described transmission assembly, wherein, described first, second and composite characteristic value comprise at least a in transonic wavelength, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and the mechanical fatigue strength.
(14) as (11) described transmission assembly, wherein, described composite characteristic value is the transonic wavelength, and the length of described composite end effector approximates 1/4th of described transonic wavelength greatly.
(15), wherein, vibrate on described composite end effector at least one in vertical, horizontal and torsional direction of longitudinal axis with respect to described end effector as (11) described transmission assembly.
(16) as (11) described transmission assembly, wherein, the described ground floor of the whole basically covering of the described second layer.
(17) as (11) described transmission assembly, wherein, described ground floor is by at least a formation the in aluminium alloy and the titanium alloy.
(18) as (17) described transmission assembly, wherein, described second material is by at least a formation the in aluminium alloy, titanium alloy, aluminium oxide ceramics, sapphire, ruby, aluminium nitride, zirconium oxide, carborundum, silicon nitride, silver, copper, gold and the copper alloy.
(19) as (11) described composite end effector, wherein, described ground floor is connected to the described second layer by at least a in sintering process, soldering processes and the mechanical technology.
(20) a kind of composite end effector that is used for ultrasonic surgical instrument, described composite end effector comprises multilamellar, wherein, two-layer at least in the described multilamellar formed by different materials, makes described composite end effector show enhanced resistance to crack propagation when being excited by the ultrasonic energy input.
(21) a kind of transmission assembly that is used for ultrasonic surgical instrument, described ultrasonic surgical instrument comprises the end effector that is formed by at least two parts, first in the described part is formed by first material, second portion in the described part is resisted against in the described first and by second material that is different from described first material along the longitudinal axis of described end effector and forms, wherein, when being excited by the ultrasonic energy input, described first material list reveals first eigenvalue, when being excited by described ultrasonic energy input, described second material list reveals second eigenvalue, when being excited by described ultrasonic energy input, described end effector shows composite characteristic value, and described composite characteristic value is different from described first and second eigenvalues.
It is clear that other embodiment of composite end effector will become from following description, accompanying drawing and claims.
Description of drawings
Fig. 1 is the axonometric chart of distal part of the ultrasonic surgical instrument of prior art;
Fig. 2 is the axonometric chart that is installed to first embodiment of the end effector on the transmission waveguide pipe far-end;
Fig. 3 is the cutaway view along the line 3-3 intercepting of end effector shown in Figure 2;
Fig. 4 is the axonometric chart that is installed to second embodiment of the end effector on the transmission waveguide pipe far-end;
Fig. 5 is the cutaway view along the line 5-5 intercepting of end effector shown in Figure 4;
Fig. 6 is the cutaway view along the line 6-6 intercepting of end effector shown in Figure 4;
Fig. 7 is the axonometric chart that is installed to the 3rd embodiment of the end effector on the transmission waveguide pipe far-end;
Fig. 8 is the cutaway view along the line 8-8 intercepting of end effector shown in Figure 7;
The coordinate diagram of Fig. 9 illustrates the result that the mathematical model of the composite end effector that use forms by titanium alloy and aluminium oxide ceramics is analyzed, wherein, D represents the diameter of aluminium oxide ceramics, and L represents when composite end effector half by the composite wavelength (inch) of ultrasonic energy when exciting of input; And
Figure 10 is the front view of the alternative part of device shown in Figure 2.
The specific embodiment
Fig. 1 is the axonometric chart of distal part of the ultrasonic surgical instrument of prior art, totally represents with 10.Ultrasonic surgical instrument 10 also is known as the ultrasonic clamp coagulator device, and openly is to authorize July 3 calendar year 2001 in the United States Patent (USP) 6,254,623 of Haibel etc.Ultrasonic surgical instrument 10 is examples in many ultrasonic surgical instruments, by composite end effector described herein is provided, for some Surgery Treatment, can improve these ultrasonic surgical instruments.Ultrasonic surgical instrument 10 can may be operably coupled to hand-held ultrasonic drive unit, and this ultrasonic drive unit is driven by the ultrasonic generator (not shown).Ultrasonic surgical instrument 10 comprises ultrasound-transmissive assembly 16, and ultrasound-transmissive assembly 16 has elongated transmission waveguide pipe 18.Waveguide 18 can be semiflexible or be inflexible basically.Waveguide 18 will amplify and will be transferred to end effector 20 from the vibration of ultrasonic drive unit, as known in the art.The distal end of end effector 20 can be vibrated in the vertical with the supersonic frequency of 55.5kHz, the peak-to-peak amplitude of about 10-200 micron.Elongated shell 14 keeps the near-end of waveguide 18 and end effector 16.Holder arms 12 is mounted to the far-end of shell 14 pivotly.The surgeon can keep tissue against end effector 20 by operated from a distance holder arms 12, is end effector 10 energizes simultaneously, to cut and/or to make coagulation of tissues.
End effector 20 and waveguide 18 can be formed by the titanium alloy such as Ti-6A-4V, aluminium alloy or any other suitable material monolithic ground.As a kind of selection, end effector 20 can perhaps be formed separately by alternative material by forming separately with waveguide 18 identical materials.Then, end effector 20 can be by for example being threaded or welding node is mounted to waveguide 18.As known in the art, the near-end of end effector 20 can be located near the vibration nodal point of the farthest side of waveguide 18.The far-end of end effector 20 is corresponding to vibratory anti-nodal point.Therefore, for the incoming frequency of special ultrasonic energy, the length of end effector 20 approximate greatly end effector material component the feature wave length of sound 1/4th.For example, when end effector 20 was formed by Ti-6Al-4V, characteristic wavelength approximately was 87mm, and the length of end effector 20 approximately is 22mm.
The axonometric chart of Fig. 2 illustrates the distal part of first embodiment of the ultrasound-transmissive assembly 22 that is used for ultrasonic surgical instrument.Fig. 3 is the cutaway view that the line 2-2 along Fig. 2 of assembly 22 is intercepted.Assembly 22 comprise can with existing waveguide 18 similar waveguides 24 shown in Figure 1.The far-end of waveguide 24 is mounted to the near-end and close first vibration nodal point 28 of composite end effector 30.Node 28 can also be located near the near-end of end effector 20 slightly.Coordinate system shown in Figure 2 is defined as the longitudinal axis 40 of assembly 22 and is parallel to the Z axle.Composite end effector 30 comprises the cylindrical first 38 with circular cross section.First 38 has hole 34 (being also referred to as the chamber), and hole 34 and longitudinal axis 40 are coaxial and extend between the far-end of end effector 30 and near-end.Columniform second portion 36 can be positioned at 34 inside, hole and can be full of hole 34 basically.Should be noted that hole 34 in the first 38 is shown as extends near vibration nodal point 28, and still, the alternative method of this method allows hole 34 to extend to the sub-fraction of single or multiple wavelength in the material, up to extending through whole wave guide pipe 24.
First 38 can be formed by first material, and first material can be any in the suitable material, comprises titanium alloy such as Ti-6Al-4V and the aluminium alloy such as 7075-T6.First 38 provides firm relatively outer cover for second portion 36, to resist structural stress in normal gripping, assembling and the operation of ultrasonic surgical instrument.When the ultrasonic energy input that for example can be provided by the ultrasonic drive unit of ultrasonic surgical instrument activated, first 38 was for example with first wavelength characteristic ground (wherein " characteristic ground " refers to the acoustic characteristic that material shows naturally) vibration.The example of ultrasonic energy input is to import about 3 watts with the frequency of about 55.5kHz.The example of first wavelength is about 87mm.
Second portion 36 is formed by second material, and second material can be any in the suitable material, comprises aluminium oxide, aluminium nitride, zirconium oxide, carborundum, silicon nitride, sapphire and ruby.Second portion 36 can only extend the part or the whole length of end effector 30.When being activated separately by the ultrasonic energy input, second portion 36 is for example with the vibration of second wavelength characteristic ground.Second wavelength can be roughly greater than first wavelength of first 38.The example of second wavelength is about 174mm.
First 38 and second portion 36 can use a kind of in a large amount of known process or be connected is in the same place, and includes but not limited to soldering, sintering and mechanical connection.When first 38 with second portion 36 links together and when being excited by ultrasonic energy input, composite end effector 30 is with the vibration of the ground of the composite wavelength characteristic between first and second wavelength.For example, if first wavelength of first 38 is about 87mm and second wavelength of second portion 36 is about 174mm, then composite wavelength can drop in the scope of about 87mm to 174mm.Except being used for the material of first 38 and second portion 36, the accurate amplitude of composite wavelength can depend on other factors, comprises the bond strength between physique, mass ratio and distribution and first 38 and the second portion 36.
Similarly, although it is unnecessary, but one or more other materials characteristics also can have composite characteristic value, and material behavior comprises the fatigue strength of thermal conductivity, coefficient of friction (just material how with tissue interaction), ultrasonic energy delivery efficient and end effector 30.In addition, each composite characteristic value relevant with material behavior can be in the eigenvalue institute restricted portion by the material behavior of first 38 and second portion 36.
Composite end effector 30 can be constructed to make its near-end near the vibration nodal point 28 of the farthest side of waveguide 24, and makes the length of composite end effector 30 approximate 1/4th of composite wavelength greatly.Therefore, the length of composite end effector 30 only can obviously be longer than by a kind of material (for example titanium alloy) make have like configurations and with the length of the end effector of ultrasonic energize.
As shown in Figure 2, second portion 36 can have unified diameter on its whole length.First 38 and second portion 36 can be linked together with combining closely, and have minimum gap on the whole zone between the opposed facing surface, to guarantee the optimum performance of composite end effector 30 always.The method that is used to make composite end effector 30 can comprise provides first bar that is formed by first material such as titanium alloy, and for example handles vertical hole of extending between the near-end that is created in first bar and the far-end by boring.For example, first bar can have about five millimeters external diameter, and vertically the hole can have about four millimeters diameter.This method also comprises provides second bar that is formed by second material such as synthetic sapphire, and the diameter of adjusting second bar makes in its vertical hole that closely is engaged in first bar.This method also comprises first bar is connected to second bar by connecting technology.Connecting technology for example can be the combination of sintering process, soldering processes, mechanical technology or these technologies.
Sintering and soldering processes be used for making biocompatible, sealing, long lasting, be known by the pacemaker housing cardiac pacemaker industry of " feedthrough " of conducting electricity.Sintering process comprises and can be used for and will be bonded to the pottery of the metal such as titanium, rustless steel or molybdenum to the metal sealing technology such as 95% aluminium oxide or 100% aluminium oxide (sapphire).Pottery (for example second portion 36 of the end effector among Fig. 2 30) can use powder refractory metal or thin film sputtering metal spray coating technique to carry out metal and handle.Then, metallized pottery can keep high pressure and stand hyperpyrexia on a period of time metal (for example first 38 of the end effector among Fig. 2 30), so that pottery and melts combine are in the same place.
Although consider the propagation of ultrasonic energy input, brazing alloy is " loss " (just they can not be propagated acoustic energy effectively and be easy to produce apace heat) normally, but also can use brazing alloy (for example silver-colored, gold or gold-copper) that second portion 36 and first 38 solderings are in the same place.But service wear material in the component of end effector 30 (comprising that the loss material of using such as silver-colored, golden forms second portion 36) will allow end effector 30 to be particularly suitable for use in the fluid environment potentially.For example, the surgeon uses ultrasonic surgical instrument to cut and/or make the coagulation of tissues that is immersed in the body fluid usually.The feasible heat from end effector of body fluid dissipates fast.As a result, cut and/or make the required time of coagulation of tissues significantly to increase, this cost is very high for patient.For such Surgery Treatment, the ultrasonic instrument with end effector of being made up of the loss material can be provided, even when end effector is immersed in the body fluid, end effector also is specially adapted to cutting and makes coagulation of tissues.
Second portion 36 also can be formed by second material as the excellent heat conductivity body, for example aluminium alloy.In operating process, the heat that produces in the tissue can conduct to waveguide 24 apace, and waveguide 24 can be used as fin, helps prevent the life-span of the overheated of end effector 30 and prolongation end effector 30 thus.
First 38 and second portion 36 can be formed by identical materials, for example titanium alloy.Such end effector 30 can keep the acoustic characteristic of selected materials, can also help opposing more because the crack propagation inefficacy that fault in material or first 38 lip-deep " scar " produce.
Second portion 36 mechanically connected or be coupled to first 38 and can comprise second portion 36 is press fit in the hole 34 of first 38 or with first 38 and mechanically be pressed on the second portion 36.Replacedly, can use heat treatment, for example, wherein before being placed on second portion 36 in the hole 34, first 38 is heated to increase the diameter in hole 34.Then, can allow the assembly cooling, make first 38 tighten on second portion 36.As known to those skilled in the art, can also use various other known mechanical treatments.
The axonometric chart of Fig. 4 illustrates the distal part of second embodiment of the ultrasound-transmissive assembly 42 that is used for ultrasonic surgical instrument.Fig. 5 is the cutaway view that the line 5-5 along among Fig. 4 of assembly 42 is intercepted.Fig. 6 is the cutaway view that the line 6-6 along among Fig. 4 of assembly 42 is intercepted.Assembly 42 can comprise waveguide 44, and waveguide 44 can be similar to the prior art waveguide 18 shown in Fig. 1.The far-end of waveguide 44 can be mounted to the near-end and close first vibration nodal point 48 of composite end effector 50.Coordinate system shown in Figure 4 is defined as the longitudinal axis 60 of assembly 42 and is parallel to the z axle.Composite end effector 50 can comprise the cylindrical first 58 with circular cross section.First 58 can have 54, the first holes 54, first hole can and longitudinal axis 60 is coaxial and extend between the far-end of end effector 50 and intermediate point 46.It is coaxial and extend between the intermediate point 46 of composite end effector 50 and near-end that first 58 can also have 64, the second holes 64, second hole and longitudinal axis 60.Columniform second portion 56 can be positioned at first hole 54 and can fill up first hole 54 basically.Columniform third part 66 can be positioned in second hole 64 and can fill up second hole 64 basically.
First 58 can be formed by first material, and first material can be any in the suitable material, comprises titanium alloy such as Ti-6Al-4V and the aluminium alloy such as 7075-T6.First 58 provides relative firm outer cover for second portion 56 and third part 66.When being activated by the ultrasonic energy input, first 58 is with the vibration of first wavelength characteristic ground.Second portion 56 can be formed by second material, and second material can be any in the suitable material, comprises aluminium oxide, aluminium nitride, zirconium oxide, carborundum, silicon nitride, sapphire and ruby.When being activated separately by the ultrasonic energy input, second portion 56 is with the vibration of second wavelength characteristic ground.Third part 66 can be formed by the 3rd material, and the 3rd material can be any in the suitable material, comprises aluminium oxide, aluminium nitride, zirconium oxide, carborundum, silicon nitride, sapphire and ruby.When being activated separately by the ultrasonic energy input, third part 66 is with the vibration of three-wavelength characteristic ground.
First 58, second portion 56 and third part 66 can be used a kind of in a large amount of known process or be connected and be in the same place, and include but not limited to soldering, sintering and mechanical connection.Composite end effector 50 is with peak in first, second and three-wavelength and the vibration of the ground of the composite wavelength characteristic between the minimum.
Composite end effector 50 can be constructed to make its near-end near the vibration nodal point 48 of the farthest side of waveguide 44, and its length approximates 1/4th of composite wavelength greatly.Therefore, the length of composite end effector 50 only can obviously be longer than by a kind of material (for example titanium alloy) make have like configurations and with the length of the end effector of ultrasonic energize.
As illustrated in Figures 5 and 6, the diameter of third part 66 can be less than the diameter of second portion 56.Need such layout, make end effector 50 be enough to resist the structural stress that the transition position between waveguide 44 and end effector 50 produces.Replacedly, the diameter of third part 66 also can be equal to or greater than the diameter of second portion 56.In addition, the 3rd material of third part 66 can be identical or different with second material of second portion 56.
The length of second portion 56 and third part 66 can change.The pattern length of second portion 56 and third part 66 can be substantially equal to or less than the length of end effector 50.
The axonometric chart of Fig. 7 illustrates the distal part of the 3rd embodiment of the ultrasound-transmissive assembly 62 that is used for the surgery ultrasonic instrument.Fig. 8 is the cutaway view that the line 8-8 along among Fig. 7 of assembly 62 is intercepted.Assembly 62 can comprise waveguide 64, and waveguide 64 can be similar to prior art waveguide 18 shown in Figure 1.The far-end of waveguide 64 can be mounted to the near-end and close first vibration nodal point 68 of composite end effector 70.Coordinate system shown in Figure 7 is defined as the longitudinal axis 80 of assembly 62 and is parallel to the z axle.Composite end effector 70 can comprise the first 78 of being made by first material, the second portion of being made by second material 72 and the third part of being made by the 3rd material 74.Three parts can be around longitudinal axis 80 coaxial arrangement, and any one or the multiple connection technology described before using link together.When being excited by the ultrasonic energy input, first, second and the 3rd material show to characteristic first, second and the 3rd wave length of sound respectively.First, second and the 3rd material can comprise the combination in any of the material of selecting from the same material of describing for first and second embodiment before.First 78 can have cylindrical shape, and wherein extend on the whole length of composite end effector 70 in first hole 76, and can keep second portion 72.Second portion 72 can have cylindrical shape, and wherein extend on the whole length of composite end effector 70 in second hole 77, and can keep third part 74.Third part 74 can be to fill up the bar in second hole 77 basically.End effector 70 can have minimum in first, second and three-wavelength and the composite wavelength between the peak.
Second portion 72 also can be formed by tubular material, make second portion 72 limit passage or chamber, and third part 74 is formed by the fluid such as air, other gases or liquid that is included in passage or the chamber.Second and third part 72,74 can on the whole length of end effector 70, extend or only on the partial-length of end effector 70, extend.
Those skilled in the art will recognize that composite end effector can comprise a plurality of parts, wherein each part can have any one in a large amount of structures, and these parts can link together with in a large amount of layouts any one.Each part can be by forming with the identical or different material of the material of any other parts.Therefore, composite end effector with required characteristics combination can be provided, composite wavelength, structural strength, structure (comprise length), Mass Distribution, manufacturing cost, service life, the heat conductivity of these characteristics combination when being excited by ultrasonic energy input is relevant with heat generation, but is not limited to this.Each part can be by a kind of formation the in the multiple material, wherein every kind of material is at the eigenvalue of being expressed material behavior by the ultrasonic energy input when exciting, and wherein composite end effector show with the eigenvalue of each material when being excited by the ultrasonic energy input in any one different composite characteristic value.
Can also form and the ultrasonic surgical instrument of a plurality of parts of linking together provides composite end effector for having by material, make that when being excited composite end effector shows enhanced resistance to the crackle that passes the end effector propagation by ultrasonic energy.At least one part can be the laminated portions that is connected to adjacent part, makes the crackle that produces in the laminated portions can not propagate and passes adjacent part.
For example, in the dwell of cam 72,74 and 78 of the end effector shown in Fig. 7 each can be formed and linked together by titanium alloy (for example Ti-6Al-4V), the crackle that produces in (outward) part 78 of winning can not propagated in the adjacent part 72, prolonged the service life of end effector 70 thus.Because the damage from other surgical instrumenties cracks in the first 78 probably.Because first 78 is relatively little parts of end effector 70, so it breaks and can not produce enough impedances and end end effector 70.In this way, do not become absorb damaging aspect the ability of non-functional parts, end effector 70 can be firmer than non-stacked end effector.
Composite end effector for example disclosed herein can use the finite element analysis technology to come modeling, to estimate composite wavelength.The curve chart of Fig. 9 illustrates and uses the result who analyzes with the mathematical model of the end effector 30 similar composite end effectors of Fig. 2.In model, composite end effector has columniform outside, and this outside is made by the titanium alloy such as Ti-6Al-4V and had vertical hole along its whole length.The outside has the external diameter of 6.35mm.100% aluminium oxide ceramics (sapphire) bar is full of the hole fully, and is assumed to be " ideally " and is mounted to titanium alloy.The diameter of " D " expression aluminium oxide ceramics bar." L " expression when exciting composite end effector with ultrasonic energy input with 55.5kHz frequency, half of the composite wavelength (inch) by model prediction.
Shown in the mathematical model among Fig. 9, when the diameter of second portion was roughly zero at the some place by letter " A " expression, half-wavelength was predicted to be about 44mm.This is corresponding to the whole situation about being formed by first material (titanium alloy) of end effector.When the diameter of second portion was approximately 5mm at the some place by letter " B " expression, half-wavelength was predicted to be about 74mm.This covers situation on the sapphire core body corresponding to only extremely thin titanium alloy shell.
For to having the composite end effector prediction composite wavelength of a plurality of parts that form by multiple material, can develop complicated mathematical model more.By carrying out the test repeatedly of mathematical model, can further develop and improve these mathematical modeies.
Figure 10 is the substituted device of device shown in Figure 2, and wherein ultrasound-transmissive assembly 122 is made up of waveguide 124, and waveguide 124 has on the near-end that is installed to composite end effector 124 and the far-end of close first vibration nodal point 128.Node 128 can also be orientated the near-end of close slightly end effector 130 as.Coordinate system shown in Figure 10 is defined as the longitudinal axis 140 of assembly 122 and is parallel to the z axle.Composite end effector 130 can comprise cylindrical first 136 and the second portion 138 that all has circular cross section, but any cross section all is suitable.In addition, various piece can also have circular hole, and this hole is filled up in mode similar to the above by unshowned third part.
First 136 can be formed by first material, first material can be any in a large amount of suitable materials of selecting according to one or more material behaviors, comprise titanium alloy, the aluminium alloy such as 7075-T6, aluminium oxide, aluminium nitride, zirconium oxide, carborundum, silicon nitride, sapphire and ruby such as Ti-6Al-4V, material behavior includes but not limited to the velocity of sound, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and fatigue strength.When the ultrasonic energy input that for example can be provided by the ultrasonic drive unit of ultrasonic surgical instrument activated, first 136 was for example with first wavelength characteristic ground (wherein " characteristic ground " refers to the acoustic characteristic that material shows naturally) vibration.The example of ultrasonic energy input is to import about 3 watts with the frequency of about 55.5kHz.The example of first wavelength is about 87mm.
Second portion 138 can be formed by second material, second material can be any in a large amount of suitable materials of selecting according to one or more material behaviors, comprise titanium alloy, the aluminium alloy such as 7075-T6, aluminium oxide, aluminium nitride, zirconium oxide, carborundum, silicon nitride, sapphire and ruby such as Ti-6Al-4V, material behavior includes but not limited to the velocity of sound, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and fatigue strength.When being activated separately by the ultrasonic energy input, second portion 138 is for example with second wavelength characteristic ground (wherein " characteristic ground " refers to the acoustic characteristic that material shows naturally) vibration.Second wavelength can be roughly greater than first wavelength of first 136.The example of second wavelength is about 174mm.
First 136 and second portion 138 can use a kind of in a large amount of known process or be connected is in the same place, and includes but not limited to soldering, sintering and mechanical connection.When first 136 with second portion 138 links together and when being excited by ultrasonic energy input, composite end effector 130 is with the vibration of the ground of the composite wavelength characteristic between first and second wavelength.For example, if first wavelength of first 136 is about 87mm and second wavelength of second portion 138 is about 174mm, then composite wavelength can drop in the scope of about 87mm to 174mm.Except being used for the material of first 136 and second portion 138, the accurate amplitude of composite wavelength can depend on other factors, comprises the bond strength between physique, mass ratio and distribution and first 136 and the second portion 138.
Similarly, although unnecessary, one or more other materials characteristics also can have composite characteristic value, and material behavior comprises the fatigue strength of thermal conductivity, ultrasonic energy delivery efficient, coefficient of friction and end effector 130.In addition, each composite characteristic value relevant with material behavior can be in the eigenvalue institute restricted portion by the material behavior of first 136 and second portion 138.
Composite end effector 130 can be constructed to make its near-end near the vibration nodal point 128 of the farthest side of waveguide 124, and makes the length of composite end effector 130 approximate 1/4th of composite wavelength greatly.Therefore, the length of composite end effector 130 only can obviously be longer than by a kind of material (for example titanium alloy) make have like configurations and with the length of the end effector of ultrasonic energize.
For the embodiments described herein, supposed mainly vibration in the vertical of end effector, to cut and to make coagulation of tissues.But end effector also mainly vibrates in any one in following direction or the combination: vertical (along the z axle), horizontal (perpendicular to the z axle) and torsional direction (around the z axle).Although it all is straight shall also be noted that the embodiment of all composite end effectors shown in the figure, composite end effector also can be crooked or have in a large amount of other structures any one.
Although, should be appreciated that those skilled in the art can make amendment to some embodiment diagram and described composite end effector.Composite end effector can comprise such modification and only be limited by the scope of claim.

Claims (21)

1. composite end effector that is used for ultrasonic surgical instrument comprises:
By the first that first material forms, described first material is being shown first eigenvalue by the ultrasonic energy input when exciting; And
By the second portion that second material forms, described second material is being shown second eigenvalue by described ultrasonic energy input when exciting;
Wherein, described composite end effector shows and the different composite characteristic value of described first and second eigenvalues when being excited by described ultrasonic energy input.
2. composite end effector as claimed in claim 1 is characterized by, and described composite characteristic value is in by the described first and second eigenvalue restricted portions.
3. composite end effector as claimed in claim 1 is characterized by, and described first, second and composite characteristic value comprise at least a in transonic wavelength, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and the mechanical fatigue strength.
4. composite end effector as claimed in claim 1 is characterized by, and described first, second and composite characteristic value are the transonic wavelength, and the length of described composite end effector approximates 1/4th of described composite characteristic value greatly.
5. composite end effector as claimed in claim 1 is characterized by, and vibrates on described composite end effector at least one in vertical, horizontal and torsional direction of longitudinal axis with respect to described composite end effector.
6. composite end effector as claimed in claim 1 is characterized by, and described first end comprises the chamber that keeps described second portion.
7. composite end effector as claimed in claim 1 is characterized by, and described first material comprises at least a in aluminium alloy and the titanium alloy.
8. composite end effector as claimed in claim 7, it is characterized by, described second material comprises at least a in aluminium alloy, titanium alloy, aluminium oxide ceramics, sapphire, ruby, aluminium nitride, zirconium oxide, carborundum, silicon nitride, silver, copper, gold and the copper alloy.
9. composite end effector as claimed in claim 6 is characterized by, and described chamber is vertical hole, and described second portion fills up described hole basically.
10. composite end effector as claimed in claim 1 is characterized by, and described first is connected to described second portion by at least a in sintering process, soldering processes and the mechanical technology.
11. transmission assembly that is used for ultrasonic surgical instrument, described ultrasonic surgical instrument comprises the end effector that is formed by two-layer at least, ground floor in the described layer is formed by first material, the second layer in the described layer coaxially is received on the described ground floor and by second material that is different from described first material and forms, wherein, when being excited by the ultrasonic energy input, described first material list reveals first eigenvalue, when being excited by described ultrasonic energy input, described second material list reveals second eigenvalue, when being excited by described ultrasonic energy input, described end effector shows composite characteristic value, and described composite characteristic value is different from described first and second eigenvalues.
12. transmission assembly as claimed in claim 11 is characterized by, described composite characteristic value is the eigenvalue between described first and second eigenvalues.
13. transmission assembly as claimed in claim 11 is characterized by, described first, second and composite characteristic value comprise at least a in transonic wavelength, heat conductivity, ultrasonic energy delivery efficient, coefficient of friction and the mechanical fatigue strength.
14. transmission assembly as claimed in claim 11 is characterized by, described composite characteristic value is the transonic wavelength, and the length of described composite end effector approximates 1/4th of described transonic wavelength greatly.
15. transmission assembly as claimed in claim 11 is characterized by, and vibrates on described composite end effector at least one in vertical, horizontal and torsional direction of longitudinal axis with respect to described end effector.
16. transmission assembly as claimed in claim 11 is characterized by, the described ground floor of the whole basically covering of the described second layer.
17. transmission assembly as claimed in claim 11 is characterized by, described ground floor is by at least a formation the in aluminium alloy and the titanium alloy.
18. transmission assembly as claimed in claim 17, it is characterized by, described second material is by at least a formation the in aluminium alloy, titanium alloy, aluminium oxide ceramics, sapphire, ruby, aluminium nitride, zirconium oxide, carborundum, silicon nitride, silver, copper, gold and the copper alloy.
19. composite end effector as claimed in claim 11 is characterized by, described ground floor is connected to the described second layer by at least a in sintering process, soldering processes and the mechanical technology.
20. composite end effector that is used for ultrasonic surgical instrument, described composite end effector comprises multilamellar, wherein, two-layer at least in the described multilamellar formed by different materials, makes described composite end effector show enhanced resistance to crack propagation when being excited by the ultrasonic energy input.
21. transmission assembly that is used for ultrasonic surgical instrument, described ultrasonic surgical instrument comprises the end effector that is formed by at least two parts, first in the described part is formed by first material, second portion in the described part is resisted against in the described first and by second material that is different from described first material along the longitudinal axis of described end effector and forms, wherein, when being excited by the ultrasonic energy input, described first material list reveals first eigenvalue, when being excited by described ultrasonic energy input, described second material list reveals second eigenvalue, when being excited by described ultrasonic energy input, described end effector shows composite characteristic value, and described composite characteristic value is different from described first and second eigenvalues.
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US8394115B2 (en) 2013-03-12
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JP5154113B2 (en) 2013-02-27
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CA2582344C (en) 2015-06-16
US20070225608A1 (en) 2007-09-27

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